Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

Status Completed

Clinical Trial Summary

Clinical Trial Description

A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD). Patients who are either treatment naive or only recently started treatment (</= 6 months of prior treatment) will be randomized in a 1:1 assignment to receive either oral mycophenolate mofetil (MMF) and a placebo (Plac) or a combination of oral MMF and oral pirfenidone (PFD), with both regimens administered for 18 months. The primary hypothesis is that the rapid onset and anti-fibrotic effects of PFD, which have been observed in the treatment of Idiopathic Pulmonary Fibrosis (IPF), will complement the delayed antiinflammatory and immunosuppressive effects of MMF, to produce a significantly more rapid and/or greater improvement in lung function over time than occurs in patients receiving control therapy with MMF and Plac. ;

Study Design

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Clinical Trial Details

NCT number	NCT03221257
Study type	Interventional
Source	University of California, Los Angeles
Contact
Status	Completed
Phase	Phase 2
Start date	November 28, 2017
Completion date	June 13, 2022

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See also
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Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate — SLSIII

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms